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临床试验/DRKS00010169
DRKS00010169招募中不适用

Identification of neutralizing antibodies against severe or chronic infections of human being - INA

niversitätsklinikum Köln0 个研究点目标入组 1,000 人开始时间: 2016年4月13日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
18 Years 至 65 Years(—)
性别
All

入选标准

  • Patients suffering from chronic infections or passing trough severe infections within the last 10 years or healthy people as volunteers, and Karnofsky > 80

排除标准

  • -Leukopenia < 2.000 Leukocytes/µl
  • -Hb < 10 g/dl
  • -Platelets < 50.000 Plateelts/µl
  • -Known acquired or hereditary coagulation disorder, including anticoaguant treatment
  • -CHF NYHA II-IV
  • -COPD GOLD Stadium III-IV
  • -History of myocardial infarcation or current symptomatic coronary artery disease
  • -Symptomatic cardiac or pulmonary disease
  • -Body weight below 45 kg (for an apheresis or blood draw of > 250 mL, a body weight of 50 kg is required)
  • -< 8 (men) or 12 (women) weeks since last blood donation or blood draw volume of > 100 mL
  • -Within 1 week after small surgery (biopsy, tooth extraction), or within 1 month after larger surgery (e.g., thoracotomoy, open abdominal surgery) or surgery with high risk of postoperative bleeding (e.g., tonsillectomy)
  • -Acute or unknown health deterioration
  • -Participation in another interventional study
  • If a leukapheresis is planned, the following additional exclusion criteria apply:
  • -History of significant complication from leukapheresis or citrate-based anticoagulation
  • -INR > 1.5 or aPTT > 60 s
  • -Premenopausal women that cannot rule out pregnancy at the time of apheresis

研究者

发起方
niversitätsklinikum Köln

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